Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Risk of COVID_19

• Conditions: COVID-19 Pneumonia
• Interventions: Other: Covid_19

• Registration Number: NCT05398731
• Lead Sponsor: Assiut University

Brief Summary

1. To determine the risk of COVID -19 in patients who use ACEI and ARBS

2. To determine the Effect of ACEI and ARBS on COVID -19 infection .

3. To determine the Severity of COVID -19 in patients who use ACEI and ARBS .

Detailed Description

SARS -CORONA VIRUS -2 (COVID-19 disease) is an infectious disease caused by the SARS-CoV-2 virus The virus enters the body through the nose, eyes, or mouth. The spike protein binds specifically to the ACE2 receptors present on the type 2 pneumocytes in the alveoli in the lungs . (Fehr and Perlman, 2015) The binding of the ACE2 receptor allows the entry of the virus into the host cell .

The virus enters the host cell either by direct cell entry by membrane fusion or by endocytosis .(Wang , et al. 2008).

ACE inhibitors (angiotensin converting enzyme inhibitors) work by preventing angiotensin I from converting into angiotensin II. (Byrd,et al. 2019)

ARBs (Angiotensin receptor blockers)reduce the action of the hormone angiotensin II, by blocking receptors that the hormone acts on, specifically AT1 receptors, which are found in the heart, blood vessels and kidneys. (Byrd,et al. 2019) ACE inhibitors and ARBs are used to treat high blood pressure and congestive heart failure, to prevent kidney failure in patients with high blood pressure or diabetes, and to reduce the risk of stroke. (Byrd,et al. 2019) Continued use of ACEI/ARB has become controversial in the setting of COVID-19. The reason for this controversy stems from the fact that ACEIs and ARBs use may increase the expression of ACE2 receptor in animal-based studies, which is the known cellular receptor and a necessary entry point for SARS-COV-2 infection, as it has been indicated that ACE2 expression is downregulated following SARS infection, resulting in excessive activation of RAS and exacerbated pneumonia progression.(Peng Zhang.et al.april2020) It has rather been suggested that despite increasing ACE2 levels, ACE inhibitors and ARBs may rather play a protective role. ACEI, by reducing the conversion of angiotensin I (ATI) to angiotensin II (ATII) and ARBs, by reducing the binding of ATII to angiotensin I receptor may tilt the scale suggested by Bombardini et al. in favour of a protective ACE2-signalling pathway .( Bombardini T, Picano E.2020).

Reynolds et.al (2020)found no association between ACE inhibitors and ARBs and increase likelihood of a positive test for covid- 19 or its severity. (Reynolds et.al (2020) However, due to lack of sufficient clinical data supporting either the beneficial or harmful effects of ACEI/ARBs use in patients with COVID-19, the optimal strategy for the management of hypertension in COVID-19 is uncertain and remains to be elucidated. So The aim of this observational study was to determine the association between hypertensive patients using ACEI/ARBs and morbidity and mortality of COVID-19.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-30
• Study Start: 2022-06
• Study First Posted: 2022-06-01
• Last Update Submitted: 2022-06-05
• Last Update Posted: 2022-06-07
• Primary Completion: 2023-03
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age >18 years old.
• patients who use ACEI
• patients who use ARBs
• patients who use other antihypertensive drugs(for example ca channel blockers or Beta blockers)
• Non hypertensive persons with matched age and sex

Exclusion Criteria

1. < 18 years old.
2. Pregnant or breast-feeding patients.
3. Patients with autoimmune disease.
4. Patients with multi organ failure, active cancer, renal insufficiency or chronic kidney disease.
5. Patients received immunosuppressive drugs.
6. Immune compromised patients.
7. Patients with obstructive lung disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients received ACEI	Covid_19	patient who use ACEI ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)
other antihypertensive drugs	Covid_19	patient who use other antihypertensive drugs(for example ca channel blockers and Beta blockers) ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)
non hypertensive group	Covid_19	Non hypertensive persons with matched age and sex
patients received ARBs	Covid_19	patient who use ARBs ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)

Primary Outcome Measures

Name	Time	Method
determine the risk of COVID -19 in patients who use ACEI and ARBS	from begining of Covid_19 pandemic up till now	determine the risk of COVID -19 in patients who use ACEI and ARBS

Secondary Outcome Measures

Name	Time	Method
determine the morbidity and Severity of COVID -19 in patients who use ACEI and ARBS	from begining of Covid_19 pandemic up till now	determine the morbidity and Severity of COVID -19 in patients who use ACEI and ARBS